A Comprehensive Analysis of In-Hospital Adverse Events After Scopolamine Administration: Insights from a Retrospective Cohort Study Using a Large Nationwide Inpatient Database

doi:10.21203/rs.3.rs-3559869/v1

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Research Article

A Comprehensive Analysis of In-Hospital Adverse Events After Scopolamine Administration: Insights from a Retrospective Cohort Study Using a Large Nationwide Inpatient Database

https://doi.org/10.21203/rs.3.rs-3559869/v1

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Background:

Scopolamine is a widely used antiemetic in anesthetic practice, particularly for postoperative and postdischarge nausea and vomiting. Despite its frequent usage and recognized efficacy, concerns have emerged regarding the potential for increased side effects, particularly in elderly patients. Further research is needed to assess safety and determine age thresholds for adverse events. This study hypothesizes associations between perioperative scopolamine use, worse clinical outcomes, increased pneumonia, delirium, urinary retention, and readmissions.

Methods:

A large, retrospective cohort study was performed using the TriNetX Analytics Network database on patients undergoing major surgical procedures between Jan 1, 2009, and March 21, 2018, to examine the impact of perioperative scopolamine use on in-hospital adverse events. Patients were divided into age groups and compared to a control group. The primary outcomes assessed were delirium, pneumonia, in-hospital death, new antipsychotic use, readmission, and new onset urinary retention within 7 days post-surgery. 1:1 propensity score matching was performed to reduce bias. Relative risk and risk differences with 95% confidence intervals were estimated.

Results:

After 1:1 propensity score matching, we identified a total of 345,812 (172,906 pairs) perioperative scopolamine users and nonusers. The cohorts of 65+, 60–64, 55–59, 50–54, and 45–49 contained 161,846 (80,923 pairs), 49,650 (24,825 pairs), 44,774 (22,387 pairs), 46,944 (23,472 pairs), and 42,598 (21,299 pairs) patients respectively. Across all age cohorts, after propensity score matching, perioperative scopolamine recipients had significantly increased relative risk and risk difference of delirium, pneumonia, in-hospital mortality, new antipsychotic use, readmission, and new-onset urinary retention.

Conclusions:

In this cohort study, perioperative scopolamine usage was associated with a significantly increased risk of in-hospital adverse events, both within the > 65 age cohort and among the 60–64, 55–59, 50–54, and 45–49 age cohorts after major surgery. These findings highlight the need for careful assessment of scopolamine's risks and benefits, especially for patients aged 45 and older. Scopolamine may be most suited for post-discharge nausea and vomiting in ambulatory patients and clinicians should reassess its standard use for postoperative nausea and vomiting, favoring shorter-acting agents with fewer side effects.

Perioperative scopolamine

Postoperative nausea and vomiting

Post-discharge nausea and vomiting

Antiemetic drugs

Delirium

Pneumonia

Urinary retention

Mortality

Readmission

Scopolamine is one of the most frequently used antiemetic drugs in anesthetic practice. However, given its 4-hour onset time, and its 72-hour duration, scopolamine is most suitable for the treatment of post-discharge nausea and vomiting (PDNV) [1]. According to consensus guidelines, the risk of experiencing delayed nausea and vomiting significantly diminishes after the age of 50, making it a less prominent concern in older populations [2]. Despite its frequent usage and recognized efficacy, concerns have emerged regarding the potential for increased side effects, particularly in elderly patients. Surprisingly, while numerous case reports have highlighted these concerns, no comprehensive study has quantified the frequency and severity of these side effects in the context of scopolamine administration in elderly patients. This critical gap in our understanding warrants further investigation to shed light on the safety and appropriateness of scopolamine use in this particular patient demographic.

Postoperative nausea and vomiting (PONV) is a common, yet complex problem affecting anesthetic care, occurring in up to 80% of high-risk patients [3–6]. Certain risk factors, such as female age, prior history of PONV, nonsmoker, and long duration of anesthesia with a volatile anesthetic, are independent predictors of PONV, increasing the incidence exponentially as more risk factors are present [7]. Furthermore, PONV is associated with prolonged hospitalizations, increased rate of readmissions, and magnified healthcare costs [8].

Scopolamine is a common agent used for the treatment of PONV and PDNV, given its long duration of activity and unique transdermal dosing regimen. The agent acts as a competitive antagonist of the acetylcholine muscarinic receptor and works primarily in smooth muscle and the central nervous system to directly antagonize cholinergic synaptic transmissions [9]. The parasympathetic activity produced leads to drying of secretions, increased cardiac output, and reduced nausea and vomiting [10]. The efficacy of scopolamine, individually and in combination with other agents such as morphine, in preventing PONV is well studied, with multiple studies identifying its effectiveness in reducing the severity and incidence of PONV [11–16]. Outside of PONV effects, scopolamine is also used in the management of excessive secretions in terminally ill patients.

Nevertheless, the elderly population faces an elevated risk of delirium and potential side effects due to scopolamine's anticholinergic properties [17]. The adverse effects of scopolamine are well documented, with patients receiving transdermal scopolamine commonly experiencing effects such as urinary retention, dry mouth, mydriasis, visual disturbances, and amblyopia [18–22]. Furthermore, the use of transdermal scopolamine may result in significant elevations in heart rate compared to placebo or glucagon [23]. The adverse effects of scopolamine have also been noted in the pediatric population, although administration of scopolamine in children remains rare [24–25]. However, it's important to note that these studies were often limited to a specific subset of post-surgical patients.

Considering that older surgical patients are susceptible to these negative outcomes and have an elevated risk of experiencing perioperative delirium, pneumonia, urinary retention, and mortality, there is a need to investigate the safety of perioperative scopolamine usage through a comprehensive healthcare database encompassing a substantial number of older adults undergoing various surgical procedures. Furthermore, it is crucial to clarify the specific age threshold at which these adverse events occur. We hypothesize that perioperative scopolamine use would be associated with worse clinical outcomes, increased risk of pneumonia, increased risk of delirium, increased risk of urinary retention, and increased rate of readmissions.

A retrospective cohort study was performed using a large, nationwide inpatient database (TriNetX Analytics Network, Cambridge, MA) to investigate the association of perioperative scopolamine use with in-hospital adverse events. TriNetX is a research platform that facilitates the collaboration and analysis of de-identified clinical data from electronic health records of millions of patients and has been used frequently to investigate clinical outcomes. The extensive database includes patient demographics, admission status, procedural notes, medication administrations, laboratory values, diagnosis codes, genomic information, and discharge status. The TriNetX platform is compliant with the Health Insurance Portability & Accountability Act and General Data Protection Regulation.

We performed a search and analysis of over 40 million patients to identify patients who underwent a major surgical procedure (cardiac, gastrointestinal, genitourinary, orthopedic, neurological, thoracic, and vascular) and received perioperative scopolamine within 24 hours of surgery between Jan 1, 2009, and March 21, 2018. Patients were identified based on diagnostic coding for surgical procedures and scopolamine administration. Major surgical procedures were defined according to the Agency for Healthcare Research and Quality classification [26–27]. Patients were subsequently divided by age into cohorts, 65+, 60–64, 55–59, 50–54, and 45–49. In the same period, patients who underwent a surgical procedure and did not receive scopolamine were included in a control group. Palliative care patients and patients with prior antipsychotic or scopolamine use were excluded.

The outcomes of interest were delirium, pneumonia, in-hospital death, new antipsychotic use, readmission, and new onset urinary retention. Similar to the intention-to-treat analysis in a randomized controlled trial (RCT), patients were monitored for outcomes up to 7 days after surgery. Patient demographics (age, sex, race, and ethnicity), comorbidities (as defined by Charlson Comorbidity Index) [28], and exposure to medications were assessed.

To minimize confounding, we performed 1:1 propensity score matching of the study cohorts (65+, 60–64, 55–59, 50–54, and 45–49) for sex, race, ethnicity, surgery type (cardiac, gastrointestinal, genitourinary, orthopedic, neurological, thoracic, and vascular), and comorbidity burden (as defined by Charlson Comorbidity Index: history of myocardial infarction, congestive heart failure, peripheral vascular disease, cerebrovascular disease, dementia, chronic obstructive pulmonary disease, connective tissue disease, peptic ulcer disease, liver disease, diabetes, hemiplegia, chronic kidney disease, tumor burden, and acquired immunodeficiency syndrome (AIDS) status). We calculated relative risk (RR), risk differences (RDs), and 95% confidence intervals (CIs) to assess the associations between perioperative scopolamine use and delirium, pneumonia, in-hospital death, new antipsychotic use, readmission, and new onset urinary retention.

We identified a total of 172,906 patients aged 45 and above who underwent a major surgical procedure and received perioperative scopolamine within 24 hours of surgery between January 1, 2009, and March 21, 2018. In the same timeframe, we identified 9,015,046 patients aged 45 and above who underwent a major surgical procedure and did not receive perioperative scopolamine. After 1:1 propensity score matching, we identified a total of 345,812 (172,906 pairs) perioperative scopolamine users and nonusers. The cohorts of 65+, 60–64, 55–59, 50–54, and 45–49 contained 161,846 (80,923 pairs), 49,650 (24,825 pairs), 44,774 (22,387 pairs), 46,944 (23,472 pairs), and 42,598 (21,299 pairs) patients, respectively. Baseline characteristics of sex, race, ethnicity, surgery type, and comorbidity burden were well balanced, with standardized mean difference less than 0.1.

Across the cohorts, after propensity score matching, perioperative scopolamine recipients had significantly increased relative risk and risk difference of delirium (Table 1), pneumonia (Table 2), in-hospital mortality (Table 3), new antipsychotic use (Table 4), readmission (Table 5), and new-onset urinary retention (Table 6). Patients in the age 65 + cohort had increased risk of delirium (826 [1.021%] vs 232 [0.287%]; RR: 3.56 [95% CI: 3.079 to 4.117], p < 0.0001), pneumonia (1,088 [1.344%] vs 638 [0.788%]; RR: 1.705 [95% CI: 1.547 to 1.88], p < 0.0001), in-hospital mortality (2,206 [2.726%] vs 303 [0.374%]; RR: 7.281 [95% CI: 6.459 to 8.206], p < 0.0001), new antipsychotic use (4,455 [5.505%] vs 1,537 [1.899%]; RR: 2.899 [95% CI: 2.737 to 3.069], p < 0.0001), readmission (278 [0.344%] vs 10 [0.012%]; RR: 27.80 [95% CI: 14.795 to 52.238], p < 0.0001), and new-onset urinary retention (734 [0.907%] vs 201 [0.248%]; RR: 3.652 [95% CI: 3.125 to 4.267], p < 0.0001).

Table 1

Association between perioperative scopolamine administration and postoperative delirium
Cohort	Patients in Cohort (after matching)	Patients with delirium	Risk (%)	Relative Risk	Confidence Interval (%)	P value
Surgery & Scopolamine 65+	80,923	826	1.021%	3.56	(3.079 to 4.117)	< 0.0001
Surgery & No Scopolamine 65+	80,923	232	0.287%
Surgery & Scopolamine 60–64	24,825	133	0.536%	3.325	(2.336 to 4.733)	< 0.0001
Surgery & No Scopolamine 60–64	24,825	40	0.161%
Surgery & Scopolamine 55–59	22,387	105	0.469%	4.375	(2.809 to 6.814)	< 0.0001
Surgery & No Scopolamine 55–59	22,387	24	0.107%
Surgery & Scopolamine 50–54	23,472	79	0.337%	2.469	(1.638 to 3.721)	< 0.0001
Surgery & No Scopolamine 50–54	23,472	32	0.136%
Surgery & Scopolamine 45–49	21,299	60	0.282%	2.857	(1.739 to 4.695)	< 0.0001
Surgery & No Scopolamine 45–49	21,299	21	0.099%

Table 2

Association between perioperative scopolamine administration and postoperative pneumonia
Cohort	Patients in Cohort (after matching)	Patients with pneumonia	Risk (%)	Relative Risk	Confidence Interval (%)	P value
Surgery & Scopolamine 65+	80,923	1,088	1.344%	1.705	(1.547 to 1.88)	< 0.0001
Surgery & No Scopolamine 65+	80,923	638	0.788%
Surgery & Scopolamine 60–64	24,825	238	0.959%	1.951	(1.569 to 2.425)	< 0.0001
Surgery & No Scopolamine 60–64	24,825	122	0.491%
Surgery & Scopolamine 55–59	22,387	172	0.768%	1.737	(1.358 to 2.223)	< 0.0001
Surgery & No Scopolamine 55–59	22,387	99	0.442%
Surgery & Scopolamine 50–54	23,472	133	0.567%	2.015	(1.501 to 2.705)	< 0.0001
Surgery & No Scopolamine 50–54	23,472	66	0.281%
Surgery & Scopolamine 45–49	21,299	95	0.446%	1.377	(1.01 to 1.876)	0.0419
Surgery & No Scopolamine 45–49	21,299	69	0.324%

Table 3

Association between perioperative scopolamine administration and postoperative mortality
Cohort	Patients in Cohort (after matching)	Deceased patients	Risk (%)	Relative Risk	Confidence Interval (%)	P value
Surgery & Scopolamine 65+	80,923	2,206	2.726%	7.281	(6.459 to 8.206)	< 0.0001
Surgery & No Scopolamine 65+	80,923	303	0.374%
Surgery & Scopolamine 60–64	24,825	182	0.733%	7	(4.643 to 10.554)	< 0.0001
Surgery & No Scopolamine 60–64	24,825	26	0.105%
Surgery & Scopolamine 55–59	22,387	104	0.465%	4.16	(2.689 to 6.435)	< 0.0001
Surgery & No Scopolamine 55–59	22,387	25	0.112%
Surgery & Scopolamine 50–54	23,472	62	0.264%	3.875	(2.237 to 6.712)	< 0.0001
Surgery & No Scopolamine 50–54	23,472	16	0.068%
Surgery & Scopolamine 45–49	21,299	35	0.164%	2.059	(1.154 to 3.674)	0.0125
Surgery & No Scopolamine 45–49	21,299	17	0.08%

Table 4

Association between perioperative scopolamine administration and postoperative new antipsychotic use
Cohort	Patients in Cohort (after matching)	Patients with new antipsychotic use	Risk (%)	Relative Risk	Confidence Interval (%)	P value
Surgery & Scopolamine 65+	80,923	4,455	5.505%	2.899	(2.737 to 3.069)	< 0.0001
Surgery & No Scopolamine 65+	80,923	1,537	1.899%
Surgery & Scopolamine 60–64	24,825	1,231	4.959%	2.876	(2.58 to 3.206)	< 0.0001
Surgery & No Scopolamine 60–64	24,825	428	1.724%
Surgery & Scopolamine 55–59	22,387	1,004	4.485%	2.91	(2.579 to 3.284)	< 0.0001
Surgery & No Scopolamine 55–59	22,387	345	1.541%
Surgery & Scopolamine 50–54	23,472	923	3.932%	2.789	(2.463 to 3.157)	< 0.0001
Surgery & No Scopolamine 50–54	23,472	331	1.41%
Surgery & Scopolamine 45–49	21,299	793	3.723%	2.782	(2.433 to 3.182)	< 0.0001
Surgery & No Scopolamine 45–49	21,299	285	1.338%

Table 5

Association between perioperative scopolamine administration and postoperative readmission
Cohort	Patients in Cohort (after matching)	Readmissions	Risk (%)	Relative Risk	Confidence Interval (%)	P value
Surgery & Scopolamine 65+	80,923	278	0.344%	27.8	(14.795 to 52.238)	< 0.0001
Surgery & No Scopolamine 65+	80,923	10	0.012%
Surgery & Scopolamine 60–64	24,825	76	0.306%	7.60	(3.932 to 14.691)	< 0.0001
Surgery & No Scopolamine 60–64	24,825	10	0.04%
Surgery & Scopolamine 55–59	22,387	53	0.237%	5.3	(2.697 to 10.415)	< 0.0001
Surgery & No Scopolamine 55–59	22,387	10	0.045%
Surgery & Scopolamine 50–54	23,472	55	0.234%	5.5	(2.804 to 10.787)	< 0.0001
Surgery & No Scopolamine 50–54	23,472	10	0.043%
Surgery & Scopolamine 45–49	21,299	80	0.376%	-	-	< 0.0001
Surgery & No Scopolamine 45–49	21,299	0	0.0%

Table 6

Association between perioperative scopolamine administration and postoperative delirium urinary retention
Cohort	Patients in Cohort (after matching)	Patients with urinary retention	Risk (%)	Relative Risk	Confidence Interval (%)	P value
Surgery & Scopolamine 65+	80,923	734	0.907%	3.652	(3.125 to 4.267)	< 0.0001
Surgery & No Scopolamine 65+	80,923	201	0.248%
Surgery & Scopolamine 60–64	24,825	119	0.479%	3.839	(2.586 to 5.697)	< 0.0001
Surgery & No Scopolamine 60–64	24,825	31	0.125%
Surgery & Scopolamine 55–59	22,387	103	0.460%	4.905	(3.069 to 7.839)	< 0.0001
Surgery & No Scopolamine 55–59	22,387	21	0.094%
Surgery & Scopolamine 50–54	23,472	87	0.371%	4.833	(2.911 to 8.026)	< 0.0001
Surgery & No Scopolamine 50–54	23,472	18	0.077%
Surgery & Scopolamine 45–49	21,299	75	0.352%	4.688	(2.733 to 8.039)	< 0.0001
Surgery & No Scopolamine 45–49	21,299	16	0.075%

Within the scope of this retrospective cohort study, we found a significant association between perioperative scopolamine administration and an elevated risk of delirium, pneumonia, new antipsychotic utilization, in-hospital mortality, readmission, and urinary retention both within the > 65 age cohort and among the 60–64, 55–59, 50–54, and 45–49 age cohorts. While scopolamine is commonly used in the perioperative setting to prevent postoperative nausea and vomiting, these results indicate a potential trade-off in terms of patient safety, particularly among the older age cohorts and those spanning from 45 to 64 years.

Notably, patients over the age of 65 may be particularly at risk for scopolamine related side effects: patients over 65 who received scopolamine were four times as likely to be readmitted after surgery compared to similar patients between 60–64 years old. In light of the growing prevalence of major surgical procedures in the aging demographic and the heightened risk of overall mortality among elderly patients who experience hospital readmissions, our findings raise concern about perioperative scopolamine usage in this patient demographic [29–32]. Similarly, patients over 65 who received scopolamine had nearly double the absolute risk of delirium and urinary retention compared to similar patients between 60–64, suggesting a potential inflection point in these adverse outcomes. The presence of delirium is an independent marker for increased mortality amongst the elderly population [33], underscoring the need for a comprehensive evaluation of alternative approaches to manage PONV in the elderly that may mitigate the risk of delirium and its associated mortality

Comparatively, the relative risk of readmission and urinary retention also shows a marked rise when contrasted with patients under 65. Surprisingly, the impact of scopolamine on urinary retention, readmission, delirium, and antipsychotic utilization is notably elevated even in patients as young as 45. In fact, younger patients were actually at higher relative risk of urinary retention, if they received scopolamine, compared to their older counterparts. These observations underscore the notion that scopolamine use carries inherent risks and should be judiciously considered, with a clear evaluation of the benefit-to-risk ratio. In cases of postoperative nausea and vomiting, alternative antiemetic options with more favorable side effect profiles may be more prudent choices over scopolamine. It is conceivable that scopolamine's utility may be best suited for younger patients and individuals with a documented history of PDNV, where its benefits may outweigh the associated risks.

The increased risk of pneumonia and the need for new antipsychotic medications following scopolamine administration suggests potential respiratory and cognitive effects. While scopolamine is intended to prevent nausea and vomiting, its anticholinergic properties may impact respiratory function and cognitive status, thereby increasing the risk of complications. The elevated risk of in-hospital mortality and readmission also has important implications for healthcare providers and policymakers. While it is essential to consider the underlying health status and comorbidities of the patient population, these findings underscore the importance of evaluating alternative strategies for managing postoperative nausea and vomiting, especially in higher-risk patients.

Selecting the age of 65 as a potential cutoff point for the use of scopolamine in the management of postoperative nausea and vomiting is a decision informed by the emerging data on its safety and efficacy. The findings from our study and previous research indicate that in patients aged over 65, the absolute risk of adverse outcomes, including delirium, pneumonia, and mortality, increases significantly following scopolamine administration. This age-based approach to scopolamine use allows for more personalized and safer postoperative care, aligning the treatment strategy with the specific needs and vulnerabilities of different patient age groups.

As with any retrospective cohort study relying on administrative data, our findings may be limited by the confines of the database and skewed by diagnostic coding errors. Diagnostic coding may overestimate or underestimate the incidence of adverse events. Additionally, the outcomes may have been influenced by unaccounted-for confounding factors that were not part of our analyses. Finally, after 1:1 propensity score matching, certain cohorts within the younger age group had limited patient numbers, which presents difficulties in extending the generalizability of our results to larger populations. The patients within the TriNetX network may not be fully representative of the entire United States population, including healthy populations and those who may not have had medical encounters with health care systems.

In this retrospective cohort study, perioperative scopolamine usage was associated with a significantly increased risk of delirium, pneumonia, new antipsychotic utilization, in-hospital mortality, readmission, and urinary retention both within the > 65 age cohort and among the 60–64, 55–59, 50–54, and 45–49 age cohorts after major surgery. These findings underscore the importance of carefully evaluating the risks and benefits of scopolamine administration in perioperative settings, particularly within these age groups. Scopolamine is most suited for post-discharge nausea and vomiting in ambulatory patients given its 4-hour onset time, and its 72-hour duration. Clinicians should reconsider scopolamine’s routine use in treating postoperative nausea and vomiting, as PONV is better treated with short acting agents, especially ones with less side effects.

PDNV: post-discharge nausea and vomiting PONV: postoperative nausea and vomiting RCT: randomized controlled trial AIDS: acquired immunodeficiency syndrome RR: relative risk RD: risk difference CI: confidence interval

Data availability:

The datasets generated and/or analyzed during the current study are available from TriNetX Analytics Network (Cambridge, MA), but restrictions apply to the availability of these data. Data is however available from the corresponding author on reasonable request and with permission of TriNetX Analytics Network.

Ethics approval and consent to participate: This retrospective study is exempt from informed consent because no protected health information is provided. We received a waiver from Thomas Jefferson University Institutional Review Board (IRB) to perform this study. The data reviewed is a secondary analysis of existing data, does not involve intervention or interaction with human subjects, and is de-identified per the de-identification standard defined in Section §164.514(a) of the HIPAA Privacy Rule. The process by which the data is de-identified is attested to through a formal determination by a qualified expert as defined in Section §164.514(b)(1) of the HIPAA Privacy Rule. This formal determination by a qualified expert was refreshed in December 2020.

Consent for publication: Not applicable.

Competing interests: The authors declare that they have no competing interests.

Funding: Not applicable.

Authors’ contributions: GS and KM conceptualized and designed the study. GS collected and organized the data, performed the initial analysis, and drafted the manuscript. KM reviewed and revised the manuscript for important intellectual content and reviewed the initial analyses. The authors read and approved the final manuscript.

Acknowledgements: Not applicable.

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A Comprehensive Analysis of In-Hospital Adverse Events After Scopolamine Administration: Insights from a Retrospective Cohort Study Using a Large Nationwide Inpatient Database

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